New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:

12/21/2005

Trade Name:

Fosamax

Generic Name or Proper Name (*):

alendronate

Indications Studied:

Severe osteogenesis imperfecta

Label Changes Summary:

* Alendronate is not indicated for use in children * The efficacy and safety were examined in a randomized, double-blind, placebo-controlled two-year study of 139 patients, 4-18 years old, with severe osteogenesis imperfecta * Treatment with alendronate did not reduce the risk of fracture * There were no statistically significant differences between the alendronate and placebo groups in reduction of bone pain * Information on PK parameters, AE profile, and clinical studies